Cleared Traditional

Aevumed PHANTOM Suture Anchors

K242895 · Aevumed, Inc. · Orthopedic
Aug 2025
Decision
317d
Days
Class 2
Risk

About This 510(k) Submission

K242895 is an FDA 510(k) clearance for the Aevumed PHANTOM Suture Anchors, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Aevumed, Inc. (Malvern, US). The FDA issued a Cleared decision on August 6, 2025, 317 days after receiving the submission on September 23, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K242895 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 2024
Decision Date August 06, 2025
Days to Decision 317 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040